Effect of GLP-1 on Intestinal Barrier Function in SBS-IF Patients: A Preliminary Exploration.

May 27, 2026 updated by: Wang Xinying, Jinling Hospital, China

Therapeutic Efficacy of GLP-1 on Intestinal Barrier Function in Patients With Short Bowel Syndrome and Intestinal Failure: A Preliminary Randomized Controlled Trial

Eligible patients were randomized into two groups: the GLP-1 group and the control group. The control group received a placebo along with standard care, without any additional GLP-1-based intervention. The GLP-1 group, in addition to standard care, received a subcutaneous injection of a GLP-1 analog (semaglutide injection) strictly according to the drug manufacturer's instructions. The initial dose of semaglutide was 0.25 mg once weekly. Treatment was continued over a 28-days period. Primary and secondary outcomes will be collected.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Eligible patients with short bowel syndrome and intestinal failure were randomly assigned to one of two groups: the GLP-1 group or the control group. The control group received a placebo along with standard care. The GLP-1 group, in addition to standard care, was administered a GLP-1 analog (semaglutide injection) via subcutaneous injection strictly according to the manufacturer's instructions, with an initial dose of semaglutide of 0.25 mg once weekly. Primary and secondary outcomes will be collected.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • China
      • Nanjing, China, China, 210002
        • Recruiting
        • Jinling Hospital
        • Contact:
      • Nanning, China, China, 210002
        • Recruiting
        • Jinling Hospital
        • Principal Investigator:
          • Xinying Wang, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Xin Qi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants voluntarily provided written informed consent for this trial;
  • Aged 18 to 80 years, inclusive, regardless of gender;
  • With stable vital signs;

  • Diagnosis of SBS-IF, confirmed by existing medical/surgical records, receiving parenteral nutrition (PN) due to surgical resection of the small intestine (<200 cm from the duodenojejunal flexure), and meeting one of the following criteria:

    • Colon continuity maintained without jejunal/ileal stoma (Type II or III);

      • Presence of a jejunostomy or ileostomy (Type I);
  • Expected requirement of PN for more than 4 weeks, with an average PN caloric intake ≥80%;
  • Ability to comply with the medication dosing and visit schedule;
  • Capacity to accurately describe symptoms, absence of severe infections or respiratory insufficiency, and willingness to cooperate proactively;
  • No history of allergic diseases, non-allergic constitution, and no hypersensitivity to any component of semaglutide injection;
  • No history of drug abuse;
  • Not pregnant or lactating; no pregnancy plans within one month after the trial (applies to both female and male participants);
  • No participation in any other drug trials (including the investigational product in this study) within three months prior to enrollment.

Exclusion Criteria:

  • Individuals who do not meet the inclusion criteria or are deemed ineligible by the investigator;
  • Poor general condition, inability to accurately describe symptoms, presence of severe infection, respiratory insufficiency, or other conditions that may hinder active cooperation;
  • History of allergic diseases, allergic constitution, or hypersensitivity to drugs structurally related to the investigational product;
  • Patients with malignancy at any site;
  • Those with psychiatric disorders, inability to cooperate, or impaired consciousness;
  • Patients with contraindications to the investigational drug (including personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2);
  • Immunodeficiency, or current use of immunosuppressants or corticosteroids;
  • Immediate family members of the sponsor, investigator, or study staff directly involved in the trial;
  • Any other condition considered by the investigator as grounds for exclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
Participants received semaglutide as a subcutaneous injection (dosage form) at a dose of 0.25 mg (dosage) once weekly (frequency) for 28 days (duration).
Drug: GLP-1 Receptor Agonists
GLP-1 receptor agonists (semaglutide) are medications that mimic the action of the native human hormone glucagon-like peptide-1 (GLP-1). The recommended dosage is 0.25 mg administered subcutaneously once weekly.
Other Names:
  • GLP-1RAs
No Intervention: Control arm
received appearance-matched placebo plus standard care, no additional semaglutide intervention therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Biomarkers of Intestinal Barrier Function
Time Frame: the initiation of enrollment and upon completion of the 28-days treatment period
Serum Citrulline（µmol/L）
the initiation of enrollment and upon completion of the 28-days treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intestinal absorption of nutrients (protein)
Time Frame: the initiation of enrollment and upon completion of the 28-days treatment period
Intestinal nitrogen balance（Kjeldahl method for total nitrogen intake and excretion）
the initiation of enrollment and upon completion of the 28-days treatment period
Intestinal absorption of nutrients (carbohydrate)
Time Frame: the initiation of enrollment and upon completion of the 28-days treatment period
Fecal carbohydrate（Fecal pH measurement and analysis of fermentable substrates for indirect assessment）
the initiation of enrollment and upon completion of the 28-days treatment period
Intestinal absorption of nutrients (fat)
Time Frame: the initiation of enrollment and upon completion of the 28-days treatment period
Fat excretion rates（van de Kamer method for direct measurement of total fecal fat excretion）
the initiation of enrollment and upon completion of the 28-days treatment period
Nutritional status indicator
Time Frame: the initiation of enrollment and upon completion of the 28-days treatment period
Serum albumin (g/L) level
the initiation of enrollment and upon completion of the 28-days treatment period
PN Liberation Rate
Time Frame: the initiation of enrollment and upon completion of the 28-days treatment period
A 20% reduction in the weekly parenteral nutrition volume from baseline
the initiation of enrollment and upon completion of the 28-days treatment period
Quality of life score
Time Frame: the initiation of enrollment and upon completion of the 28-days treatment period
Quality of life was assessed using the SF-36 score from the date of randomization until the end of the 4-week intervention weeks. SF-36 consists of eight dimensions, each of which is measured on a scale of 0-100, with higher scores indicating a better quality of life.
the initiation of enrollment and upon completion of the 28-days treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Investigators

  • Principal Investigator: Xinying Wang, MD, Jinling Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2026

Primary Completion (Actual)

May 27, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

September 19, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-09-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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